O ne product presently used for soft tissue augmentation in Europe is Sculptra (NewFill). Unlike many other fillers, this product does not itself cause soft tissue augmentation by directly replacing lost tissue. Rather, it stimulates collagen growth from innate fibroblasts. As with any new material, there will be many questions in the beginning, and I predict that the knowledge will be viral when the material is introduced into the United States. Sculptra is made from lactic acid — a substance that is familiar to dermasurgeons who have used vicryl sutures. It has been used for years in Europe and has had several publications describing its use in HIV lipoatrophy. In that population, the treatments have significantly reduced the lipoatrophy and the correction has lasted for several months to a few years. A Very Different Filler The technique for using Sculptra is very different from fillers presently used. To begin with, it comes as a lyophilized powder that is reconstituted. Several different recommendations exist for reconstitution, and they range from using 3 to 5 cc of diluent (sterile water for injection). Using lidocaine with epinephrine is probably worthwhile to increase patient comfort and one combination in frequent use is to add 1 cc of lidocaine without epinephrine with 3 cc of diluent. Interestingly, the bottle has about the same size and shape of Botox cosmetic. Once reconstituted, the material does not form a solution. Rather, it is a suspension that will precipitate with time. The rate of precipitation will probably be effected by factors from basic chemistry including pH (remember, we may or may not be adding lidocaine, which may be very acidic) and temperature (maybe warming the diluent will help maintain the suspension). Precipitation has many practical implications for the cosmetic dermasurgeon that are novel. For instance, we take for granted that what we inject at the beginning of a soft tissue augmentation procedure is identical to what is injected in the middle and end of the procedure. With this product, that is not always the case, and physicians need to take great care to maintain an even suspension throughout the procedure (gently shaking or inverting the syringe should be done throughout the procedure). Needle clogging also occurs with this product as material suspends in the needle orifice. This is easily cleared by withdrawing and agitating the product. The importance of needle clogging lies not with the inconvenience (which is minimal) but rather in the recognition that it has occurred so that excessive pressure is not applied. Many Questions I have many questions about Sculptra that will, no doubt, be answered shortly. For instance, theoretically, if one is injecting several cc of material into the skin, the suspended particles may gravitate toward one end of the treated area. Perhaps using a battery-operated massager following treatment will serve to maintain an even suspension during the time that diluent is absorbed. Manual massage is definitely recommended. Another similarity to Botox is the recommendation that product is used in a timely fashion. Sculptra is going to come with a label recommendation for use within 72 hours. However physicians using the product in England have related that the product is stable for longer than 3 days. Since reconstitution is accomplished using sterile technique, it’s possible to use one bottle for several patients as long as you use sterile needles when withdrawing material. I would be reluctant to allow multiple uses from one vial unless I observe each syringe being filled or fill it myself. Anyone who does a lot of injecting of soft tissue materials will begin to complain about some of the ergonomic problems (“dermasurgeons wrist” — a form of carpal tunnel that would be a disability in the days that physicians could still obtain those policies). Sculptra is a surprising pleasure from an ergonomic point of view — it has a low viscosity and flows like Botox. There is virtually no resistance, making smooth, even injections very possible. The Best Applications for this Filler Areas likely to be good candidates for Sculptra include the nasolabial creases, mental creases and areas of subcutaneous fat loss. Physicians experienced with the product advise against using it in the lips — and I would heed this advice — unless more experience proves otherwise. I have seen the product used in the lower canthal rim area and have been told that it gives great results there. In that area, protection of the orbit, precision placement in the deep layers (just above the periosteum) and great care in avoiding vessels are of paramount importance. Sculptra should not be used in the vermillion border of the lips. The actual injection is accomplished with a 26-gauge needle inserted into the deep dermis. Placement in the superficial dermis (raising a bleb with the needle) will increase the rate of papule formation. It’s essential to withdraw the hub of the needle to avoid intravascular placement of material. Multiple injections are needed to correct one area. One other very important aspect of injections with Sculptra is to undercorrect with each treatment. With this product, it’s not possible to accurately gauge the degree to which someone will produce collagen, so it’s imperative to avoid overcorrection. Intervals between treatments are typically 4 to 6 weeks and usually two or three treatments are planned. It is imperative to prepare patients for the fact that material injected (despite initial impression of correction) will disappear within a day or two and then gradual correction will occur based on the body manufacturing collagen. Since each patient will produce a different amount of collagen with each injection and it may take longer for some patients to produce collagen than for others, there’s no way to accurately predict whether a given patient will need one treatment with a quarter of a vial or three treatments with an entire vial. Pre-treatment counseling, explicit consent forms and printed post treatment care sheets are essential. Moving Forward There are many other issues regarding Sculptra that I have not covered (I’ll aim to cover them in a future column). For now, my message is that Sculptra is a product that will probably be a wonderful addition to the filler armamentarium. It will not be appropriate for every patient, every physician or every indication, but for the right patient, physician and indication it will be a wonderful alternative.
Getting to Know Sculptra
O ne product presently used for soft tissue augmentation in Europe is Sculptra (NewFill). Unlike many other fillers, this product does not itself cause soft tissue augmentation by directly replacing lost tissue. Rather, it stimulates collagen growth from innate fibroblasts. As with any new material, there will be many questions in the beginning, and I predict that the knowledge will be viral when the material is introduced into the United States. Sculptra is made from lactic acid — a substance that is familiar to dermasurgeons who have used vicryl sutures. It has been used for years in Europe and has had several publications describing its use in HIV lipoatrophy. In that population, the treatments have significantly reduced the lipoatrophy and the correction has lasted for several months to a few years. A Very Different Filler The technique for using Sculptra is very different from fillers presently used. To begin with, it comes as a lyophilized powder that is reconstituted. Several different recommendations exist for reconstitution, and they range from using 3 to 5 cc of diluent (sterile water for injection). Using lidocaine with epinephrine is probably worthwhile to increase patient comfort and one combination in frequent use is to add 1 cc of lidocaine without epinephrine with 3 cc of diluent. Interestingly, the bottle has about the same size and shape of Botox cosmetic. Once reconstituted, the material does not form a solution. Rather, it is a suspension that will precipitate with time. The rate of precipitation will probably be effected by factors from basic chemistry including pH (remember, we may or may not be adding lidocaine, which may be very acidic) and temperature (maybe warming the diluent will help maintain the suspension). Precipitation has many practical implications for the cosmetic dermasurgeon that are novel. For instance, we take for granted that what we inject at the beginning of a soft tissue augmentation procedure is identical to what is injected in the middle and end of the procedure. With this product, that is not always the case, and physicians need to take great care to maintain an even suspension throughout the procedure (gently shaking or inverting the syringe should be done throughout the procedure). Needle clogging also occurs with this product as material suspends in the needle orifice. This is easily cleared by withdrawing and agitating the product. The importance of needle clogging lies not with the inconvenience (which is minimal) but rather in the recognition that it has occurred so that excessive pressure is not applied. Many Questions I have many questions about Sculptra that will, no doubt, be answered shortly. For instance, theoretically, if one is injecting several cc of material into the skin, the suspended particles may gravitate toward one end of the treated area. Perhaps using a battery-operated massager following treatment will serve to maintain an even suspension during the time that diluent is absorbed. Manual massage is definitely recommended. Another similarity to Botox is the recommendation that product is used in a timely fashion. Sculptra is going to come with a label recommendation for use within 72 hours. However physicians using the product in England have related that the product is stable for longer than 3 days. Since reconstitution is accomplished using sterile technique, it’s possible to use one bottle for several patients as long as you use sterile needles when withdrawing material. I would be reluctant to allow multiple uses from one vial unless I observe each syringe being filled or fill it myself. Anyone who does a lot of injecting of soft tissue materials will begin to complain about some of the ergonomic problems (“dermasurgeons wrist” — a form of carpal tunnel that would be a disability in the days that physicians could still obtain those policies). Sculptra is a surprising pleasure from an ergonomic point of view — it has a low viscosity and flows like Botox. There is virtually no resistance, making smooth, even injections very possible. The Best Applications for this Filler Areas likely to be good candidates for Sculptra include the nasolabial creases, mental creases and areas of subcutaneous fat loss. Physicians experienced with the product advise against using it in the lips — and I would heed this advice — unless more experience proves otherwise. I have seen the product used in the lower canthal rim area and have been told that it gives great results there. In that area, protection of the orbit, precision placement in the deep layers (just above the periosteum) and great care in avoiding vessels are of paramount importance. Sculptra should not be used in the vermillion border of the lips. The actual injection is accomplished with a 26-gauge needle inserted into the deep dermis. Placement in the superficial dermis (raising a bleb with the needle) will increase the rate of papule formation. It’s essential to withdraw the hub of the needle to avoid intravascular placement of material. Multiple injections are needed to correct one area. One other very important aspect of injections with Sculptra is to undercorrect with each treatment. With this product, it’s not possible to accurately gauge the degree to which someone will produce collagen, so it’s imperative to avoid overcorrection. Intervals between treatments are typically 4 to 6 weeks and usually two or three treatments are planned. It is imperative to prepare patients for the fact that material injected (despite initial impression of correction) will disappear within a day or two and then gradual correction will occur based on the body manufacturing collagen. Since each patient will produce a different amount of collagen with each injection and it may take longer for some patients to produce collagen than for others, there’s no way to accurately predict whether a given patient will need one treatment with a quarter of a vial or three treatments with an entire vial. Pre-treatment counseling, explicit consent forms and printed post treatment care sheets are essential. Moving Forward There are many other issues regarding Sculptra that I have not covered (I’ll aim to cover them in a future column). For now, my message is that Sculptra is a product that will probably be a wonderful addition to the filler armamentarium. It will not be appropriate for every patient, every physician or every indication, but for the right patient, physician and indication it will be a wonderful alternative.
O ne product presently used for soft tissue augmentation in Europe is Sculptra (NewFill). Unlike many other fillers, this product does not itself cause soft tissue augmentation by directly replacing lost tissue. Rather, it stimulates collagen growth from innate fibroblasts. As with any new material, there will be many questions in the beginning, and I predict that the knowledge will be viral when the material is introduced into the United States. Sculptra is made from lactic acid — a substance that is familiar to dermasurgeons who have used vicryl sutures. It has been used for years in Europe and has had several publications describing its use in HIV lipoatrophy. In that population, the treatments have significantly reduced the lipoatrophy and the correction has lasted for several months to a few years. A Very Different Filler The technique for using Sculptra is very different from fillers presently used. To begin with, it comes as a lyophilized powder that is reconstituted. Several different recommendations exist for reconstitution, and they range from using 3 to 5 cc of diluent (sterile water for injection). Using lidocaine with epinephrine is probably worthwhile to increase patient comfort and one combination in frequent use is to add 1 cc of lidocaine without epinephrine with 3 cc of diluent. Interestingly, the bottle has about the same size and shape of Botox cosmetic. Once reconstituted, the material does not form a solution. Rather, it is a suspension that will precipitate with time. The rate of precipitation will probably be effected by factors from basic chemistry including pH (remember, we may or may not be adding lidocaine, which may be very acidic) and temperature (maybe warming the diluent will help maintain the suspension). Precipitation has many practical implications for the cosmetic dermasurgeon that are novel. For instance, we take for granted that what we inject at the beginning of a soft tissue augmentation procedure is identical to what is injected in the middle and end of the procedure. With this product, that is not always the case, and physicians need to take great care to maintain an even suspension throughout the procedure (gently shaking or inverting the syringe should be done throughout the procedure). Needle clogging also occurs with this product as material suspends in the needle orifice. This is easily cleared by withdrawing and agitating the product. The importance of needle clogging lies not with the inconvenience (which is minimal) but rather in the recognition that it has occurred so that excessive pressure is not applied. Many Questions I have many questions about Sculptra that will, no doubt, be answered shortly. For instance, theoretically, if one is injecting several cc of material into the skin, the suspended particles may gravitate toward one end of the treated area. Perhaps using a battery-operated massager following treatment will serve to maintain an even suspension during the time that diluent is absorbed. Manual massage is definitely recommended. Another similarity to Botox is the recommendation that product is used in a timely fashion. Sculptra is going to come with a label recommendation for use within 72 hours. However physicians using the product in England have related that the product is stable for longer than 3 days. Since reconstitution is accomplished using sterile technique, it’s possible to use one bottle for several patients as long as you use sterile needles when withdrawing material. I would be reluctant to allow multiple uses from one vial unless I observe each syringe being filled or fill it myself. Anyone who does a lot of injecting of soft tissue materials will begin to complain about some of the ergonomic problems (“dermasurgeons wrist” — a form of carpal tunnel that would be a disability in the days that physicians could still obtain those policies). Sculptra is a surprising pleasure from an ergonomic point of view — it has a low viscosity and flows like Botox. There is virtually no resistance, making smooth, even injections very possible. The Best Applications for this Filler Areas likely to be good candidates for Sculptra include the nasolabial creases, mental creases and areas of subcutaneous fat loss. Physicians experienced with the product advise against using it in the lips — and I would heed this advice — unless more experience proves otherwise. I have seen the product used in the lower canthal rim area and have been told that it gives great results there. In that area, protection of the orbit, precision placement in the deep layers (just above the periosteum) and great care in avoiding vessels are of paramount importance. Sculptra should not be used in the vermillion border of the lips. The actual injection is accomplished with a 26-gauge needle inserted into the deep dermis. Placement in the superficial dermis (raising a bleb with the needle) will increase the rate of papule formation. It’s essential to withdraw the hub of the needle to avoid intravascular placement of material. Multiple injections are needed to correct one area. One other very important aspect of injections with Sculptra is to undercorrect with each treatment. With this product, it’s not possible to accurately gauge the degree to which someone will produce collagen, so it’s imperative to avoid overcorrection. Intervals between treatments are typically 4 to 6 weeks and usually two or three treatments are planned. It is imperative to prepare patients for the fact that material injected (despite initial impression of correction) will disappear within a day or two and then gradual correction will occur based on the body manufacturing collagen. Since each patient will produce a different amount of collagen with each injection and it may take longer for some patients to produce collagen than for others, there’s no way to accurately predict whether a given patient will need one treatment with a quarter of a vial or three treatments with an entire vial. Pre-treatment counseling, explicit consent forms and printed post treatment care sheets are essential. Moving Forward There are many other issues regarding Sculptra that I have not covered (I’ll aim to cover them in a future column). For now, my message is that Sculptra is a product that will probably be a wonderful addition to the filler armamentarium. It will not be appropriate for every patient, every physician or every indication, but for the right patient, physician and indication it will be a wonderful alternative.
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